ACLU sues to challenge FDA limits on access to abortion pill

The American Civil Liberties Union sued Tuesday in a challenge to federal restrictions that limit many women’s access to the so-called abortion pill.

The lawsuit, filed in U.S. District Court in Hawaii, targets long-standing restrictions imposed by the Food and Drug Administration that say the pill, marketed in the U.S. as Mifeprex, can be dispensed only in clinics, hospitals and doctors’ offices. The lawsuit contends the drug — used for abortions up to 10 weeks of pregnancy — should be made available by prescription in pharmacies across the U.S.

“The abortion pill is safe, effective and legal. So why is the FDA keeping it locked away from women who need it?” said Julia Kaye, an attorney with the ACLU Reproductive Freedom Project. “The FDA’s unique restrictions on medication abortion are not grounded in science — this is just abortion stigma made law.”

The restrictions have been in place since the drug was approved for use in the U.S. in 2000. They stipulate that Mifeprex may not be sold in pharmacies and that all providers of the drug undergo a special certification process.

The FDA issued new guidelines for the use of Mifeprex last year, and said at the time that the restrictions continue to be necessary to ensure safe use of the drug.

The FDA confirmed this week that the agency’s position has not changed since then. Regarding the lawsuit, it said the agency does not comment on pending or ongoing litigation.

The suit was filed on behalf of three health care associations and a physician, Graham Chelius. He works on the Hawaiian island of Kauai, which currently has no abortion providers.

Chelius, a family medicine doctor, says he is qualified and willing to provide medication abortion, but is unable to stock the abortion pill at the hospital where he works because of objections from some colleagues. As a result, he says, his patients must carry an unwanted pregnancy to term or make a 300-mile round trip flight to another island to get an abortion — boosting costs and sometimes delaying the procedure by several weeks. This could be avoided if the pill were available at pharmacies on Kauai.

The lawsuit is supported by the American Congress of Obstetricians and Gynecologists. Its CEO, Dr. Hal Lawrence, said there is no medical justification for the FDA restrictions.

According to a commentary earlier this year in the New England Journal of Medicine, 19 deaths have been reported to the FDA among the more than 3 million women who have used Mifeprex in the U.S. since 2000, a mortality rate lower than for pregnancy-related deaths among women.

The commentary suggested that lifting the FDA restrictions would likely increase the number of doctors willing to prescribe Mifeprex, since they would no longer have to stock the drug in their office and no longer have to be on a list of certified abortion providers. Easing the rules also might help make medical abortion more available via telemedicine to women in rural areas who live far from the nearest abortion facility, said the 10 co-authors, who included doctors and academics from Stanford, Princeton and Columbia universities.

According to the latest federal figures, medical abortions — generally a two-pill regimen using Mifeprex and the drug misoprostol — accounted for about 22 percent of abortions in the U.S. in 2013. Surgical procedures accounted for nearly all the other abortions.

Women using the pill generally take it in the privacy of their home. Noting that, Kaye said the legal case “is primarily about where a woman must be standing when she’s handed the abortion pill that’s been prescribed to her.”

“The FDA restriction defies common sense,” she said. “There’s no medical issue in whether she’s handed the pill at a pharmacy or at a clinic.”

There is precedent for a federal court to overturn FDA restrictions. In 2013, a federal judge in New York ordered that the most common version of the morning-after pill must be accessible over-the-counter for all customers of all ages, instead of requiring a prescription for girls 16 and younger.

10 Responses

Ditto,,,I forward thee aclu EVERY DAY,,,THE LIST OF OUR DEAD,,ANY NEWS ARTICLE OF DENIAL OF CARE,,, every day,,,So they know of the torture and genocide these opiatephobs have done to us..I saw in a reply somewhere,,,THEE ACLU IS MONITOREING THE PLIGHT OF CHRONIC PAIN PATIENT CLOSELY,,,thats great,,,just keep watchen us die,,literally being tortured to death ACLU!!!!!!maryw

The ACLU cannot and will not do anything. They are flooded with complaints from pain patients daily. They deal in Constitutional law ONLY. We do not have a Constitutional right to receive pain medicine. No doctor is bound by the Constitution to prescribe pain meds. No pharmacy is bound by the Constitution to dispense pain meds. The one and only time a government agency can be sued is if they lie. They did and do lie. The Nazi DEA run rouge and false statistics. Petitions do nothing. Emails, letters and phone calls do nothing. Believe me, I know. I have been doing that since 2013 and the former National President of the ACLU that still is a lawyer, that I have known since high school informed me. They are required to exam every single complaint they get, even if its as rediculous as you used a bug spray and got a mosquito bite.They are trying to fight saying drug tests are a violation of rights. Who cares. It doesnt mean they cannot be done even if they win. I only care about them since Blue Cross just decided they are “not medically necessary” and my adjusted cost that does not apply to my deductible is $400.00. So, youre barking up the wrong tree. Besides, pain doesnt even exist. The AMA removed it as 1 of the 5 ways to diagnose a patient. It has been removed from all doctor/hospital surveys. The entire pain subject part has been removed from the official website of my disease. I see one person noted with it on this site commited suicide. It had a 10% suicide rate when high dose and slow release narctotics were used. I say contact Al Sharpton, bus in paid protesters to raise holy hell and get media attention. NOTHING has helped. Things just get worse and worse. I STILL see pain groups with thousands of members being instructed to take this or that paper from a study or doctor on the benefits of opiods and they will get their meds back. That is downright scarey! Just keep watching the “news” with prescription bottles as props talking about the newest in our FAKE opiod crisis with Fentanyl. I assure you, no doctor prescribes Fentanyl pills. One kills you. (As did the musician, Prince) Heroin use is up 300-900% since 2013. Media buries it. Suicides skyrocketing. Media buries it. Christie was the final nail in our coffin. NOTHING in this country ever changed from polite petitions. Real great when they start “I hate taking pain pills, but……” Thats as far as it goes. You got your wish. You wont have to worry about taking pills you hate.

we do have TWO LAWS about discriminating against those with disabilities and/or discriminating against a particular segment of our society.. The Americans with Disability Act and the Civil Rights Act… however… those two laws are enforced by parts of the same Fed agency – DOJ – that also includes the DEA. Hell will probably freeze over before one part of the bureaucracy forces another part to enforce our laws.

But as far as the ACLU this has nothing to do with the Constitution. They will not do anything. Period. I keep seeing time and time again someone excited that the ACLU is reviewing their case. They are required to. They won’t do anything. The way I see it is that the public believes that doctors hand out pills like candy. Politicians want votes. They do not care about complaints from us. All people see is “Opiod Crisis, overdoses, can’t use Benzos. Doctors turn people into addicts” That us what the general public believes. Until public perception is changed, nothing will change. This MUST be done with demonstrations, protests and an arrests. We have to get media attention. No one can get it together and understand this. Start “Go Fund Me” for bail money. Bus in paid protesters if need be. Stop with the petitions and contacting politicians. It has done nothing in years. Why does anyone think it will work now? It won’t. Now we are told to learn to live with it or take a Tylenol. It gets worse and worse and worse.

Wendy,,I agree w/u about the ACLU,,, personally I think its because SOOO MANY of their financial contribution come from the very people doing this top us,,the kolodyns,,the politicians,insurance companies,,i even saw a drug addiction racket donationg to the ACLU,,we recently did a 3rd request for legal assistant w/the aclu and for a formal referral to the National ACLU,, again denied,,no reason,,and when I called to ask why,,I got hung up on in New York,This was a no stone unturned request,,,,we put EVERYTHING in this formal request,,,Which comes 1 disagreement I have w/your reply..The Constitutional violations have everything to do w/it..We listed at least 8 violation of our constitution,,along w/violations of thee disabilities rights/act,,Literally 3 pages of the laws they/federal government has truthfully broken, Practicing medicine w/out a license,,etc,,Again we left nothing out,,Dea abuses, politician re-writing definition for future financial gain in employments after wards,..Sorry the ACLU pissis me off,,,cause when-ever u get soooo much corruption, from a agency that is suppose to help people like us,,,we know its money,,,they must get financial contribution from all of those,,who are doing this to us,,maryw

Denial of effective medical care that causes severe physical pain,is thee International definition of Torture..Death onto a group of people based upon the disability is genocide..The United States are guilty on both counts,,,and numerous other violation of International law regarding degrading treatment etc,,,,,
I guess we should just stop fighten then eh??Sorry not this lady,,,when I live in this country,,and this body,,whats left of it..For if we wish to become a civil humane society as our fore fathers designed America to be,,,then ,”we the people,” fight for it,,,,”When any form of government Evinces BY DESIGN,, to reduce its citizens to absolute despotism,,it our duty,,our right,,to alter or abolishe it,,”,,,,,,,,freedom aint free,,,maryw

Steve have you tried filing with the ACLU in regards to helping chronic pain patients? I have gotten denied. Not giving up though. They were taking the approach that the CDC had guidlines not laws. Talk to my Dr. A lot of help they were. Please respond. Claudine in Indiana

I know of others who have filed complaints about the CDC guidelines… and have gotten no where… IMO.. the CDC does not have legal/statue authority to create such guidelines .. since their authority is dealing with contagious diseases and chronic pain is not a contagious disease. Since these are guidelines and now law.. I guess that they cannot be challenged in a court of law as to their constitutionality ? But other entities (hospitals, VA, insurance companies, PBM, chain pharmacies .. have latches on to these guidelines and adopted them as a standard of care and best practices. These opiate conversion tables that they are using .. admit in their own footnotes.. that AT BEST… THEY ARE CRUDE ESTIMATES… but the CDC and others have adopted them as absolute BLACK/WHITE formulas when moving from one opiate to another to calculate MME (Morphine Mg Equivalents). I suggest that you read this http://nationalpainreport.com/do-we-need-to-educate-the-professionals-8836437.html IMO.. everyone is either using the law and/or skirting the laws to discriminate against the chronic pain community and it going to take law firms dealing with civil rights and/or personal injury to help level the playing field.

When Walmart/Sam’s Club implemented their 2016 unlawful mandate coercing the refusal of valid opioid prescriptions, subsequently forcing the pharmacist to violate Guaranteed Patient Rights under HHS, CMS and the ADA, I notified the ALCU of the Rights violations. They, like all the regulatory agencies notified, failed to take any action against the overzealous corporate policy making that denies care and endangers public safety. Do not hold your breath that they will step up to protect CPP rights.